02082nas a2200265   4500000000100000008004100001100001400042700001400056700001500070700001200085700001400097700001400111700001200125700001500137700001300152700001500165700001300180700001300193700001900206245011700225250001500342490000700357520140100364020005101765       2015                            d1 aCass Alan1 aHawley C.1 aPilmore H.1 aGarg A.1 aPascoe E.1 aIerino F.1 aKrum H.1 aRoberts M.1 aBadve S.1 aVergara L.1 aIsbel N.1 aTonki A.1 aPerkovic Vlado00aThe rationale and design of the Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study  a2014/11/110 v203 a<p>
AIMS: The BLOCADE Feasibility Study aims to determine the feasibility of a large-scale randomised controlled trial with clinical endpoints comparing the beta-blocking agent carvedilol to placebo in patients receiving dialysis. METHODS: The BLOCADE Feasibility Study is a randomised, double blind, placebo-controlled, parallel group feasibility study comparing the beta-blocking agent carvedilol to placebo. Patients receiving dialysis for &gt;/=3 months and who are aged &gt;/=50 years, or who are &gt;/=18 years and have diabetes or cardiovascular disease, are eligible. The primary outcome is the proportion of participants who complete a 6-week Run-in phase in which all participants receive carvedilol titrated from 3.125mg twice daily to 6.25mg twice daily. Other measures include how many patients are screened, the proportion recruited, the overall recruitment rate, the proportion of participants who remain on study drug for 12 months and the incidence of intra-dialytic hypotension while on randomised treatment. RESULTS: The BLOCADE Feasibility Study commenced recruiting in May 2011 and involves 11 sites in Australia and New Zealand. CONCLUSIONS: The BLOCADE Feasibility Study will inform the design of a larger clinical endpoint study to determine whether beta-blocking agents provide benefit to patients receiving dialysis, and define whether such a study is feasible.
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